A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

NCT00108524 | Completed Results

• 1 other identifier: CLIN-005-03F
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).

Conditions

Diabetes Mellitus; Obesity

Keywords

anti-obesity agents; diet therapy; diet, reducing; obesity; overweight; risk factors; weight loss

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Body Weight at 48 Weeks

  Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.

  baseline and 48 weeks

Secondary Outcomes (2)

• Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks

  baseline and 48 weeks

• Change From Baseline in Blood Sugar at 48 Weeks

  Baseline and 48 weeks

Study Arms (2)

Low Carbohydrate Ketogenic Diet

EXPERIMENTAL

Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.

Behavioral: Low carbohydrate ketogenic diet

Low-Fat Diet plus Orlistat

ACTIVE COMPARATOR

Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.

Drug: Orlistat; Behavioral: Low-fat diet

Interventions

Low carbohydrate ketogenic diet BEHAVIORAL

A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.

Low Carbohydrate Ketogenic Diet

Orlistat DRUG

In addition to the low fat diet, Orlistat is taken 3 times daily.

Also known as: Xenical

Low-Fat Diet plus Orlistat

Low-fat diet BEHAVIORAL

Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake

Low-Fat Diet plus Orlistat

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a VA medical center primary care provider;
• Failed first line diet and exercise recommendations;
• In stable health by screening physical and lab tests;
• Agrees to make regular visits per study protocol;
• Has access to telephone;
• Body mass index (BMI) \> or = 27 with obesity-related illness OR BMI \> or = 30 with no risk factors;
• No contraindications to Orlistat;
• Not pregnant or breast-feeding;
• No serious mental health illness such as dementia or schizophrenia;
• No use of a weight loss therapy in the month prior to screening.

You may not qualify if:

• No VAMC primary care provider
• Unable to attend regular study visits
• No access to telephone
• BMI \< 27
• Contraindications to Orlistat
• Pregnancy, breast feeding or planning to become pregnant
• Unstable mental health illness
• Use of a weight loss therapy in the month prior to screening

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Durham VA Medical Center HSR&D COE

Durham, North Carolina, 27705, United States

Location

Related Publications (3)

• Mayer SB, Jeffreys AS, Olsen MK, McDuffie JR, Feinglos MN, Yancy WS Jr. Two diets with different haemoglobin A1c and antiglycaemic medication effects despite similar weight loss in type 2 diabetes. Diabetes Obes Metab. 2014 Jan;16(1):90-3. doi: 10.1111/dom.12191. Epub 2013 Aug 29.

  PMID: 23911112 RESULT

• Yancy WS Jr, Almirall D, Maciejewski ML, Kolotkin RL, McDuffie JR, Westman EC. Effects of two weight-loss diets on health-related quality of life. Qual Life Res. 2009 Apr;18(3):281-9. doi: 10.1007/s11136-009-9444-8. Epub 2009 Feb 11.

  PMID: 19212822 RESULT

• Yancy WS Jr, Westman EC, McDuffie JR, Grambow SC, Jeffreys AS, Bolton J, Chalecki A, Oddone EZ. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss. Arch Intern Med. 2010 Jan 25;170(2):136-45. doi: 10.1001/archinternmed.2009.492.

  PMID: 20101008 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Overweight; Weight Loss

Interventions

Orlistat; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

We provided orlistat at no cost. This could have increased dietary adherence, attendance, and/or retention compared with the LCKD and may lead to different results than what might be seen in patients who must pay for orlistat.

Results Point of Contact

• Title: William S Yancy, Jr. MD, MHSc
• Organization: Durham VAMC

william.yancy2@va.gov

919-286-0411

Study Officials

• William S. Yancy, MD MHS

  Durham VA Medical Center HSR&D COE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2005
• First Posted: April 18, 2005
• Study Start: July 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 17, 2014
• Results First Posted: December 12, 2013

Record last verified: 2014-03

Locations

US (1)